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Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae

Phase 3
Completed
Conditions
Digestive Fistulae
Interventions
Registration Number
NCT00729313
Lead Sponsor
Ipsen
Brief Summary

The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.

Detailed Description

The purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
111
Inclusion Criteria
  • Patient with pancreatic, duodenal, or small intestine fistula
  • Patient with simple, externalised fistula
  • Patient with fistula for which a medical conservative treatment is considered
  • Patient with:
  • for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively,
  • for duodenal and small intestine fistulae: a mean drainage volume more than or equal to 100ml/24h over 2 days
Exclusion Criteria
  • Patient expected to require a surgical treatment of the fistula during the study
  • Patient having uncontrolled intra-abdominal sepsis; Crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies.
  • Patient receiving long-term corticotherapy
  • Patient having received any somatostatin analogue as curative treatment of the fistula or any PRF somatostatin analogue within the previous month.
  • Patient having previously undergone a transplant

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Lanreotide microparticlesDrug: Lanreotide 30 mg microparticle formulation One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of lanreotide 30 mg microparticle formulation every 10 days): according to the patient's treatment response at 72h For non-responders patients lanreotide will be stopped.
2PlaceboOne intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of placebo every 10 days): according to the patient's treatment response at 72h. Non-responder patients having received placebo on the first injection should receive an open-labelled lanreotide treatment.
Primary Outcome Measures
NameTimeMethod
Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.Fistula drainage volume on 3rd day.
Secondary Outcome Measures
NameTimeMethod
Pancreatic or duodenal and small intestine fistula closing rate within D60Day 60
Number of injections received by each patientEnd of study
Percentage of fistula recurrence during the follow-up periodDuration of follow-up period for each patient is of 1 month
Percentage of mortality in each groupEnd of study
Closure time of digestive fistulae will be defined by the interval between D0 (day of the first injection) and the date of spontaneous closure of the fistula.Day 60

Trial Locations

Locations (18)

Hôpital Nord

🇫🇷

Marseille, France

CHU J. Minjoz

🇫🇷

Besançon, France

Hôpital Avicenne

🇫🇷

Bobigny, France

Hôpital de la Cavale Blanche

🇫🇷

Brest, France

Hôpital Louis Mourier

🇫🇷

Colombes, France

Hôpital Henri Mondor

🇫🇷

Créteil, France

Hôpital A. Michallon

🇫🇷

Grenoble, France

CHU de Bicêtre

🇫🇷

Kremlin Bicêtre, France

Hôpital Edouard Herriot

🇫🇷

Lyon, France

Hotel Dieu

🇫🇷

Lyon, France

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Hôpital Nord
🇫🇷Marseille, France

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